MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-11 for 3.5V RECHARGABLE HANDLE 71000-A manufactured by Welch Allyn, Inc..
[20125231]
The customer placed a new battey recently purchased from a distributor in his handle that he has had since 1987/88. The handle had not been in use for 5 years. The customer plugged the handle into the wall outlet and let the room for 5 minutes. When he returned, there was smoke in the room and a blackened area around the wall outlet. The customer stated that he found the handle on the floor and the prongs still in the outlet. There was no allegation of injury.
Patient Sequence No: 1, Text Type: D, B5
[20264408]
Welch allyn is reporting this event in an abundance of caution. The actual device was returned to welch allyn for review by engineering. The investigation is not yet complete. A follow-up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2014-00013 |
| MDR Report Key | 4359851 |
| Report Source | 05 |
| Date Received | 2014-12-11 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2015-01-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEARLEY BHAMBRI, DIRECTOR |
| Manufacturer Street | 4341 STATE ST. RD. P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5V RECHARGABLE HANDLE |
| Generic Name | NONE |
| Product Code | FCO |
| Date Received | 2014-12-11 |
| Returned To Mfg | 2014-12-01 |
| Model Number | 71000-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE ST. RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-11 |